NCT06875661

Brief Summary

This study investigates the effectiveness of the Schroth method, a conservative physiotherapeutic approach, in the treatment of adolescent idiopathic scoliosis (AIS). AIS is a three-dimensional spinal deformity of unknown etiology that develops during growth, affecting 2-3% of the general population. While most cases are mild, some require medical intervention, including bracing or surgery. Conservative treatments, such as specific exercise programs, aim to slow progression, improve postural alignment, and enhance respiratory function. Among these, the Schroth method is widely recognized for its structured approach, emphasizing active three-dimensional posture correction, rotational breathing, and sensorimotor training. This study was designed as a randomized, single-blind, parallel-group trial conducted at Scolio Centar in Novi Sad between March and August 2023. Ethical approval was obtained from the Faculty of Sports and Physical Education, University of Novi Sad, and informed consent was secured from participants' parents. Inclusion criteria comprised a confirmed AIS diagnosis, an age range of 10-18 years, a Cobb angle greater than 10°, and no prior surgical or alternative treatment. Exclusion criteria included contraindications for exercise, psychological disorders, neuromuscular diseases, or previous spinal surgeries. The study involved 34 participants who were randomly assigned to two groups: an experimental group (EG), which underwent supervised Schroth therapy three times a week for eight weeks, and a control group (CG), which performed the same exercises independently at home. Baseline and post-intervention assessments included radiographic measurement of Cobb angle, ATR via scoliometer, respiratory function tests (VC, FVC, FEV1, FEV1/FVC ratio) using spirometry, and CE via manual measurement. Stratified randomization was used to balance the groups based on Cobb angle severity. The Schroth exercise protocol included posture correction exercises, spinal stabilization drills, and targeted breathing techniques, supervised by a certified physiotherapist for the EG. The CG received initial instruction but performed the exercises independently at home.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2023

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2023

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 7, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 13, 2025

Completed
Last Updated

March 19, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 7, 2025

Last Update Submit

March 13, 2025

Conditions

Keywords

Schroth methodAdolescent idiopathic scoliosisCobb angleSpine health

Outcome Measures

Primary Outcomes (6)

  • The Cobb angle

    The Coob angle expressed in degrees, was obtained using a standard anterior-posterior standing radiograph of the complete spine .

    8 weeks

  • Angle of trunk rotation

    The angle of trunk rotation (ATR) was measured with a Bunnell scoliometer, in a forward bending standing position. The scoliometer was placed on the patient's back cen-trally over the spine. ATR is expressed in degrees.

    8 weeks

  • Vital Capacity (VC)

    Vital Capacity (VC) as pulmonary function measured using a Spirolab Portable spirometer (MIR, Italy). The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values are expressed in liters.

    8 weeks

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity (FVC) as pulmonary function measured using a Spirolab Portable spirometer (MIR, Italy) and present maximum amount of air a person can forcibly exhale after taking a deep breath The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values in liters.

    8 weeks

  • Forced Expiratory Volume in One Second (FEV1)

    Forced Expiratory Volume in One Second (FEV1) is the amount of air a person can forcibly exhale in the first second of a forced breath after taking a deep inhalation. Measuring using a Spirolab Portable spirometer (MIR, Italy). The measurement was performed in an upright position. The procedure for each out-come was repeated three times and the average was taken as the reference value. Values are expressed in liters.

    8 weeks

  • Chest expansion

    Chest expansion was measured manually using a tape marked in millimeters. Chest expansion was measured at the junction between the xiphoid process and the body of the sternum and expressed in centimeters.

    8 weeks

Secondary Outcomes (5)

  • Date of birth

    8 weeks

  • Height

    8 weeks

  • Weight

    8 weeks

  • Gender

    8 weeks

  • Body Mass Index (BMI)

    8 weeks

Study Arms (2)

Schroth

EXPERIMENTAL

Schroth experimental group

Other: Schroth

Control

NO INTERVENTION

Group of participants without Schroth method intervention

Interventions

SchrothOTHER

Patients in the experimental group exercised for 90 minutes a day, three days a week. Schroth exercises were performed in an asymmetrical position to improve the symmetry of the trunk. These exercises include stretching, flexion, spinal lengthening, derotation, strengthening, and rotational breathing exercises. The respondents combined these exercises with everyday life activities. In the control group, subjects were taught Schroth exercises under the supervision of an authorized physiotherapist, and they were asked to practice the exercises as regularly as possible at home.

Schroth

Eligibility Criteria

Age10 Years - 18 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Diagnosis of idiopathic scoliosis; Age range of 10-18 years (adolescent); Cobb angle greater than 10; No other types of exercise, medical treatment.

You may not qualify if:

  • The existence of some contraindications for exercise, psychological problems, neuro-logical-muscular diseases; Previous spine surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Novi Sad, Faculty of Sport and Physical Education

Novi Sad, 21000, Serbia

Location

Study Officials

  • Dragan Marinkovic, Msc

    University of Novi Sad, Faculty of Sport and Physical Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lead Investigator

Study Record Dates

First Submitted

March 7, 2025

First Posted

March 13, 2025

Study Start

March 1, 2023

Primary Completion

May 1, 2023

Study Completion

May 10, 2023

Last Updated

March 19, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

Data obtained through this study may be provided to qualified researchers with academic interest in scoliosis. Data will be coded, with no PHI included. Approval of the request and execution of all applicable agreements are prerequisites to the sharing of data with the requesting party.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Data requests can be submitted starting 9 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Access Criteria
Data obtained through this study may be provided to qualified researchers with academic interest in scoliosis and spine disorders.

Locations